Scientist II – Critical Reagents (Franklin, Indiana) at B2S Life Sciences LLC

Franklin, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Sep, 26

Salary

0.0

Posted On

10 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

ELISA, Electrochemiluminescence, Protein Purification, Protein Conjugation, Bioanalytical Method Development, GLP, GXP, SOP Writing, Sample Analysis, Biophysical Characterization, Technical Writing, Troubleshooting, Microsoft Office Suite, Data Analysis, Method Validation, Immunogenicity

Industry

Biotechnology Research

Description

Description Onsite: Franklin Indiana Principal Function: The Scientist II is a part of the Bioanalytical Operations team which designs, validates and executes assays to enable clients to efficiently make data-driven decisions for optimal analytical outcomes to support biotherapeutic drug development. This includes early phase method development & qualification, validation and non-GLP & GLP sample analysis. The individual in this role ensures quality and regulatory requirements for Good Laboratory Practice (GLP) are followed. Scientist II designs and executes experiments, with minimal supervision, independently troubleshoot issues. Ability to work independently with little or no supervision. Essential Duties and Responsibilities Performs Sample Analysis. Performs in Method Qualifications. Assists with Method Development and Validation. Leads Method Development & Validation. Records and notates the experimental processes on time and in accordance with Good Documentation Practices. Performs a variety of assays including conventional Enzyme Linked Immuno Sorbent Assay (ELISA)/Electrochemiluminescence (ELISA/ECL) immunoassays. Reports and treats data with elevated level of integrity and ethics. Records and notes the experimental processes on time and in a correct documentation format. Ensures adherence to GXP. Complies with all applicable regulations and maintains proper records in accordance with standard operating procedures (SOPs) and policies. Troubleshoot existing analytical methods. With little to no supervision by PI Supports the team with investigations, reagent optimization, generation of optimal matched pair of antibodies, method qualification, and non-GLP sample analysis. Independently developments and qualifies large molecule bioanalytical methods to support a range of nonclinical/clinical studies needs including, but not limited to PK/TK, immunogenicity, biomarkers, etc. Compiles scientific data (including analysis and technical writing) in an intelligible format suitable for a professional audience. Maintains laboratory equipment, as needed. Performs all duties and responsibilities of Scientist I with increased scientific oversight and independence. Independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps abreast of literature in the biotherapeutic field. Able to take technical leadership on projects, with little to no supervision. Review current and recent technologies around protein purification, characterization, engaging new concepts as suitable to continuously improve capabilities and methods. Performs a variety of protein conjugation, protein purification and detailed bioanalytical biophysical characterization work, with little to no PI supervision. Assumes departmental responsibility for projects and may participate as representative on internal and external. Contributes to technical reports and presents results at periodic project review meetings, may deliver updates to senior level management / external clients in context of overall project goals. With minor support from PI, develops analytical methodologies, protocols, and/or test procedures that meet group client and company goals and reflect expert knowledge. Performs critical review of scientific methods and development data, and technical reports. Complies with application able regulations (GXP); maintains proper records in accordance with standard operating procedures (SOPs) and policies; independently designs and performs scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge. Writes, edits, and revises standard operating procedures (SOPs), qualifications, and forms. Contributes to defining team goals and collaborating with scientists within and outside functional areas in achieving them; assumes departmental responsibility for projects OR has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals. Ability to critically evaluate and interpret data. Willing and able to take technical leadership on projects. Plans, executes, trouble-shoots, and analyzes experiments and interpret scientific findings. May perform protein conjugation chemistry. Independently applies basic scientific principles, performs literature searches, attends scientific meetings, and keeps up to date on literature in the biotherapeutic bioanalysis field. Writes, edits, and revises standard operating procedures (SOPs), qualifications, and forms. Other duties as assigned. The Scientist II is a part of the Assay Development team which designs and executes assays that complement the company's capabilities in custom critical reagents to enable clients to efficiently make data-driven decisions for optimal analytical outcomes to support biotherapeutic drug development. To realize this goal, B2S offers a range of services from drug discovery through nonclinical/clinical development. This includes early phase ADME investigations, reagent optimization, generation of optimal matched pair of antibodies, method qualification, and non-GLP sample analysis. The Scientist II works other team members in the development and qualification of large molecule bioanalytical methods to support a range of nonclinical/clinical studies needs including, but not limited to PK/TK, immunogenicity, biomarkers, etc. The Scientist II will: Perform a variety of assays including conventional Enzyme Linked Immuno Sorbent Assay (ELISA)/Electrochemiluminescence (ELISA/ECL) immunoassays Complete sample analysis and method qualifications Troubleshoot existing analytical methods Compile scientific data (including analysis and technical writing) in an intelligible format suitable for a professional audience Record and note the experimental processes on time and in a correct documentation format Report and treat data with high level of integrity and ethics Comply with application able regulations (GXP); maintain proper records in accordance with standard operating procedures (SOPs) and policies; independently design and perform scientific experiments with a pre-defined goal including developing new methodologies, protocols, and/or test procedures that contribute to core group research goals and reflect expert knowledge Maintain laboratory equipment, as needed Perform other duties as assigned Requirements Education and/or Experience Bachelor’s Degree (B.S.) in chemistry with at least two-year of direct laboratory experience Bachelor’s Degree (B.S. or B.A.) in a related science with at least four-years of direct laboratory experience Doctorate Degree (P.H. D.) in biology or related degree with zero to two years of direct laboratory experience. An equivalent combination of related education and required work experience will be considered. Demonstrated experience in protein biochemical/biophysical techniques is preferable. Experience is strongly preferred. Competencies: Adaptability Analytical Ethics Interpersonal Skills Oral and Written Communication Problem Solving Quality and Quantity Safety and Security Teamwork Other Skills and Abilities Ability to adapt and conform to shifting priorities and demands and execute accordingly. Strong organizational and communication skills, both written and verbal. Computer software skills required include Microsoft Office Suite: Outlook, Word, Excel, PowerPoint, OneDrive, OneNote, SharePoint, and Teams. Physical Demands Ability to stand less than 1/3 of the time. Ability to walk less than 1/3 of the time. Ability to sit more than 2/3 of the time. Ability to talk or hear from 1/3 to 2/3 of the time. Ability to lift 20 lbs. less than 1/3 of the time. Work Environment The work environment is in an office/laboratory environment. Travel up to 5% percent of the time. Frequent use of a computer is necessary. This position requires working independently, as well as part of a team. The noise level in the work environment is usually moderately loud and has moderate temperatures. Personal protective equipment must be worn in designated lab areas: closed-toed shoes, laboratory coat, safety goggles, and gloves. This position requires the use of all general office equipment. Potential exposure to pathogens.

Responsibilities

The Scientist II designs, validates, and executes bioanalytical assays to support biotherapeutic drug development and sample analysis. They are responsible for leading method development, ensuring GXP compliance, and providing technical leadership on projects with minimal supervision.